Company
SynCardia Systems Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | SynCardia Systems LLC SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO Completed |
LOZ | None listed |
| Jan 27, 2023 | SynCardia Systems LLC SynCardia Total Artificial Heart System (70CC): 500101-001
SynCardia Total Artificial Heart System (50CC): 570500-000 Open, Classified |
LOZ | None listed |
| Oct 21, 2016 | SynCardia Systems Inc. 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 Terminated |
LOZ | None listed |
| Sep 17, 2015 | SynCardia Systems Inc. Temporary Total Artificial Heart (TAH-t) with Freedom Driver System
REF 595000-001
Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, wh Terminated |
LOZ | None listed |
| Dec 28, 2012 | SynCardia Systems Inc. Companion External Battery, Part Number: 293001-001
The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the tempo Terminated |
DSZ | None listed |